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Heated chemo showdown: one dose fits all or custom fit?

NCT ID NCT04779554

Disease control Sponsor: Prakash Pandalai Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests two ways of giving heated chemotherapy directly into the abdomen during surgery for advanced gastrointestinal cancers that have spread to the lining of the belly. One method uses a fixed dose for everyone, while the other adjusts the dose based on the patient's body size. The goal is to see if the weight-based approach leads to less chemotherapy entering the bloodstream, which could mean fewer side effects. About 100 people will take part in this randomized phase 2 trial.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mitomycin C (chemotherapy)
What this could lead to
If successful, this could show that weight-based dosing of heated chemotherapy is safer with fewer side effects, while still controlling the cancer.
What could go wrong
This is a phase 2 trial with only 100 people, so results are preliminary. It focuses on drug levels in the blood, not long-term survival or cure. The approach may not work for all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2021

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients diagnosed with one of the following: low-grade appendiceal mucinous neoplasm, pseudomyxoma peritonei, appendiceal cancer with peritoneal carcinomatosis, colorectal cancer with peritoneal carcinomatosis * ECOG performance status \< 3 * Candidate for grossly complete cytoreductive surgery * Life expectancy greater than 3 months * Adequate organ and marrow function * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Any extra-abdominal metastases * Untreated lung metastases * Liver metastases not amenable to resection or ablation * Known brain metastases * Chemotherapy or radiotherapy within 4 weeks prior to entering the study * Presence of residual significant adverse events attributed to prior cancer treatment * Currently receiving any other investigational therapeutic agents * History of allergic reactions attributed to compounds of similar chemical or biologic composition to Mitomycin C. * Pregnant or breast-feeding women * Uncontrolled ongoing illness

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Conditions

The condition(s) this trial relates to.

appendiceal neoplasm colorectal neoplasm peritoneal carcinomatosis peritoneal neoplasm pseudomyxoma peritonei

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Peritoneal carcinomatosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Kentucky

    RECRUITING

    Lexington, Kentucky, 40536, United States

  • University of Vermont Medical Center

    RECRUITING

    Burlington, Vermont, 05401, United States

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